Lundbeck gains US approval for Sabril

Lundbeck of Denmark's US says that the Food and Drug Administration has granted two New Drug Application approvals for Sabril (vigabatrin) tablets and oral solution. The firm plans to launch the drug in the USA in the third quarter.

Sabril is indicated as monotherapy for pediatric patients one month to two years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss, and as adjunctive (add-on) therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. It is not indicated as a first line agent for CPS.

This is said to be the first therapy approved for the treatment of IS and an important new option as add-on therapy for the approximately 30% to 36% of adults with CPS whose seizures remain uncontrolled in spite of having many antiepileptic therapies already available.

'The approval of Sabril is great news for patients and their families who have been waiting a long time for access to this new therapy,' said Donald Shields, Director of the Pediatric Epilepsy Program at the University of California at Los Angeles. 'Having more than a decade of experience with Sabril, I have felt this drug was important to the epilepsy community. Lundbeck shared my commitment to getting this important therapy approved and without their support, Sabril would not be available today in the US,' Dr Shields added.

Commenting on the approval of the lead compound in its central nervous system  pipeline, Jeffrey Aronin, chief executive of Lundbeck Inc, said: 'We have been working hard to address the unmet medical needs of patients faced with infantile spasms and to offer a new add-on option for treating refractory complex partial seizures. FDA approval of Sabril is an important victory for the entire epilepsy community.'

In conjunction with marketing approval of Sabril, Lundbeck has developed an FDA-mandated FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) to manage the risk of permanent vision loss associated with Sabril. The Sabril REMS, a critical component in receiving FDA approval, specifies elements, such as restricted product distribution, required vision testing and mandatory benefit-risk assessments, to manage the risk of permanent vision loss associated with Sabril.